MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® RS URETHRAL SUPPORT SYSTEM

Model Number	BRD300RS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Apnea (1720); Arthritis (1723); Asthma (1726); Erosion (1750); Bronchitis (1752); Cellulitis (1768); Cyst(s) (1800); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Gastritis (1874); Headache (1880); Unspecified Infection (1930); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Vomiting (2144); Chills (2191); Hernia (2240); Urinary Frequency / Polyuria (2275); Anxiety (2328); Distress (2329); Discomfort (2330); Depression (2361); Sore Throat (2396); Numbness (2415); Neck Pain (2433); Nasal Obstruction (2466); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Intermenstrual Bleeding (2665); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: ¿complications associated with the proper implantation of the align® urethral support system may include, but are not limited to: postoperative hematoma, which may occur following the implant procedure.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the mesh sling implant.Perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage.Transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion of the implant." 1994, 2348, 2371, 2993 = "nl".No sample received.
Event or Problem Description
It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, suffering, disability and impairment.
Event or Problem Description
Per additional information received on 24nov2021, the patient has experienced vaginal pain, vaginal mesh erosion, pelvic prolapse, pain during sexual intercourse, vaginal discharge and foul odor, stress incontinence, unspecified hematuria, kidney stones, low back pain, urinary tract infection unspecified site, urinary incontinence unspecified, allergic rhinitis, anxiety disorder, unspecified osteoarthritis, blurred vision, nasal stuffiness, sore throat, chronic cough, painful urination, arthritis, chronic back pain, minimal vaginal bleeding, cystocele, lesions, urinary urgency and frequency, asthma, back injury, dyspareunia, non-inflammatory disorders of vagina, frequency of micturition, chronic interstitial cystitis, overactive bladder syndrome, pain while coughing, severe abdominal pain, fever and chills, stomach pain, nausea, suprapubic pain, rectal pain, apparent distress, palpitations in the suprapubic area, post operative infection, cellulitis, abdominal bloating, acute bronchitis, nasal and chest congestion, body aches, wheezing, bladder pain, epigastric pain, vomiting, dysuria, mild tenderness in the right upper quadrant and moderate tenderness in epigastric area, acute gastritis without hemorrhage, acute cystitis, cholestasis which resulted in discomfort, left flank pain, pain in cervical spine, headache, neck pain, numbness, degenerated disc disease cervical, spasm in neck, depression, sleep disturbances, insomnia, heart murmur, pertussis, cervical radiculitis, esophagitis reflux, carpal tunnel syndrome right, recurrent bacterial vaginosis, urethral bleeding, acute vaginitis, chronic fatigue, obstructive sleep apnea and required additional surgical and non-surgical interventions.
Additional Manufacturer Narrative
1750, 2120, 1930="l".1928, 2558, 2328, 2137="nl".H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Per additional information received via medical records on 11apr2022, the patient has experienced vaginal mesh erosion, vaginal infection, pain, abdominal pain, pelvic pain, recurrence of prolapse, recurrence of incontinence, urinary problems, pain during intercourse to the point of abstaining, embarrassment, frequent urinary tract infections, pain during intercourse due to vaginal shortening from removal, adhesions, cystocele, enterocele, hernias, rectocele, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain, urinary incontinence, uterine prolapse, vaginal vault prolapse, any other disease of the gut, intestines or bowel and required additional surgical and non-surgical interventions.
Additional Manufacturer Narrative
2475, 2123, 2466, 2396, 1685, 2329, 2467, 2665, 1871, 2275 1726, 2191, 2144, 2684, 2361, 1720, 2519, 2564="nl" h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
3191="nl".H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As per the documents received via sharepoint on 17may2024, the patient experienced gastroesophageal reflux disease.
Additional Manufacturer Narrative
As per notification received via sharepoint on 17-may-2024, the date of awareness has been updated to 05-17-2024.This is a correction for the smdr submitted on 07jun2024 (b)(4) to reflect the correct mdr date of awareness of 17may2024.17may2024 is the correct date that this information was received for submission¿.3191="nl" correction- g, h.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As per the documents received via sharepoint on 17may2024, the patient experienced gastroesophageal reflux disease.

• Brand Name: ALIGN® RS URETHRAL SUPPORT SYSTEM
• Common Device Name: ALIGN® RS URETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 11706646
• Report Number: 1018233-2021-80036
• Device Sequence Number: 19833068
• Product Code: OTN
• UDI-Device Identifier: 00801741016196
• UDI-Public: (01)00801741016196
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2009
• Device Model Number: BRD300RS
• Device Catalogue Number: BRD300RS
• Device Lot Number: CVSDX032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 11/24/2021; 04/11/2022; 04/11/2022; 05/17/2024
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 12/13/2021; 05/04/2022; 06/07/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White